影响绝经后骨质疏松日本女性停服阿仑膦酸钠治疗的因素。

Factors affecting discontinuation of alendronate treatment in postmenopausal Japanese women with osteoporosis.

机构信息

Institute for Integrated Sports Medicine, Keio University School of Medicine, Tokyo, Japan.

出版信息

J Chin Med Assoc. 2009 Dec;72(12):619-24. doi: 10.1016/S1726-4901(09)70442-3.

DOI:10.1016/S1726-4901(09)70442-3

PMID:20028640

Abstract

BACKGROUND

The main challenge to the long-term treatment of osteoporosis with bisphosphonates has been patient adherence. The purposes of this cohort study were to investigate the 3-year outcome of alendronate treatment in postmenopausal Japanese women with osteoporosis and to identify factors that contributed to the discontinuation of alendronate treatment.

METHODS

A total of 72 postmenopausal Japanese women with osteoporosis and aged from 58 to 85 years were treated with alendronate in a 3-year trial. Metacarpal bone mineral density, serum alkaline phosphatase, and urinary cross-linked N-terminal telopeptides of type I collagen were monitored, and factors contributing to the discontinuation of alendronate treatment were determined.

RESULTS

Fourteen patients dropped out of the trial. The reasons for dropout were side effects (diarrhea [n = 1], gastric symptoms [n = 9], and inflammation of the mouth [n = 1]) or non-compliance (n = 3). Logistic regression analysis showed that the number of prevalent vertebral fractures was a significant factor affecting the discontinuation of alendronate treatment for the reasons listed above. In 58 patients who continued the 3-year treatment, urinary cross-linked N-terminal telopeptides of type I collagen level was reduced by 44.1% at 3 months and serum alkaline phosphatase level was decreased by 11.6%, 11.8%, and 12.5% at 1, 2, and 3 years, respectively. However, metacarpal bone mineral density did not change significantly.

CONCLUSION

Alendronate treatment decreased urinary cross-linked N-terminal telopeptides of type I collagen and serum alkaline phosphatase levels, and maintained metacarpal bone mineral density in postmenopausal Japanese women with osteoporosis. The patients adhered well to alendronate treatment in our clinic. The number of prevalent vertebral fractures was an important factor affecting the discontinuation of alendronate treatment due to side effects and non-compliance.

摘要

背景

长期使用双磷酸盐治疗骨质疏松症的主要挑战是患者的依从性。本队列研究的目的是探讨阿仑膦酸钠治疗绝经后骨质疏松症日本女性 3 年的结果，并确定导致阿仑膦酸钠治疗中断的因素。

方法

72 例绝经后骨质疏松症日本女性年龄 58-85 岁，接受为期 3 年的阿仑膦酸钠治疗。监测掌骨骨密度、血清碱性磷酸酶和尿Ⅰ型胶原交联 N 末端肽，并确定导致阿仑膦酸钠治疗中断的因素。

结果

14 例患者退出试验。退出试验的原因是副作用（腹泻[1 例]、胃部症状[9 例]和口腔炎症[1 例]）或不遵医嘱（3 例）。Logistic 回归分析显示，上述原因导致阿仑膦酸钠治疗中断的，椎体骨折数量是一个显著的影响因素。在继续 3 年治疗的 58 例患者中，尿Ⅰ型胶原交联 N 末端肽水平在 3 个月时降低了 44.1%，血清碱性磷酸酶水平在 1、2 和 3 年时分别降低了 11.6%、11.8%和 12.5%。然而，掌骨骨密度没有显著变化。